PREMIA SPINE LTD recalls TOPS Inserter, part of the TOPS System Instrument Set used for implantation of the TOPS System. Model Number: 82889.
- Recall date
- July 16, 2025
- Source
- U.S. Food & Drug Administration (FDA) — enforcement report
- Recall number
- Z-2516-2025
- FDA classification
- Class II
- Brand / firm
- PREMIA SPINE LTD
- Sold / distributed
- US Nationwide distribution in the state of Connecticut.
Why it was recalled
Potential for missing pins at tip of inserter.
Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.
What was recalled
TOPS Inserter, part of the TOPS System Instrument Set used for implantation of the TOPS System. Model Number: 82889.
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